Expert Details

Expert in Medical/Surgical Device Design, Management, Marketing, Regulatory

Expert ID: 723905 North Carolina, USA

Request Expert

A results-oriented professional with proven domestic and international experience in health care administration, medical devices, marketing, staff development, product development and management, luminary and customer liaison, public relations, technology assessment and transfer, intellectual property, research and development, clinical trials, regulatory affairs and compliance, quality systems, market and business development, professional, industry and vendor relations, volunteer management, customer retention, sales support, communications, emerging technologies, information systems and P & L management. Adept at identifying problem areas and implementing corrective actions. A team builder and leader providing motivation, training and support by example with solid communication skills at all levels. Experienced in ISO manufacturing, TQM and work with the FDA, NIH, DOD, DARPA and U.S. Air Force Research Laboratory.



Year Degree Subject Institution
Year: 1974 Degree: Doctor of Science (D.Sc.) Subject: Biochemistry, Biophysics Institution: U of London, Sussex College
Year: 1987 Degree: MHA Subject: Hospital Management Institution: U of NC at Chapel Hill - Kenan School of Management
Year: 1969 Degree: Bachelor of Science (B.S.) Subject: Ultrasonics and Anatomy Institution: Bowman Gray School of Medicine

Work History

Years Employer Title Department
Years: 1994 to Present Employer: Undisclosed Title: CONTRACT CONSULTANT Department:
CONTRACT CONSULTANT to academia, venture capitalists and medical device manufacturers providing direction and assistance in staff development, technology assessment and transfer, new product development, oncology treatment planning, surgical and cosmetic implants, regulatory submissions/defense/compliance, corporate management, staffing, professional and customer relations, staff training and retention, clinical trials and market development. Initiated and maintained strategic liaisons between manufacturers, luminaries, inventors and investors.
Years Employer Title Department
Years: 1992 to 1994 Employer: InfiMed, Inc Title: NEW PRODUCTS AND MARKET DEVELOPMENT Department:
Directed new medical imaging products development team and clinical trials; regulatory submissions and defense; initiated new market launch for the Asia/Pacific theatre and Asian OEMs; managed R & D group and technology transfer; Domestic and International travel averaged 45 per cent. Reported to Executive Vice President.
Years Employer Title Department
Years: 1990 to 1992 Employer: Medrad, Inc Title: SENIOR PRODUCT MANAGER for MAGNETIC RESONANCE Department:
Managed worldwide clinical trials, regulatory submissions, technology transfer, marketing and highly successful international launch of new MR imaging devices for imaging the human prostate, cervix and breast; directed regulatory compliance, research and development, advertising and OEM accounts; travel 50 per cent. Reported to Senior Vice President.
Years Employer Title Department
Years: 1986 to 1990 Employer: Wake Forest University Title: ADMINISTRATOR Department: Bowman Gray School of Medicine
Administration of 450 personnel including 150 faculty and house staff; managed grants, managed care contracts, physician recruitment and an annual budget of $25,000,000+. Reported to Chairman / Associate Dean.
Years Employer Title Department
Years: 1978 to 1986 Employer: Picker International Corporation Title: INTERNATIONAL PRODUCT MANAGER Department:
INTERNATIONAL PRODUCT MANAGER for Ultrasound, Nuclear and Clinical Lab/RIA product lines; directed worldwide sales, regulatory submissions and compliance, technology transfer, marketing and service for 96 dealers and 3 OEMs in 105 countries; International travel 85 per cent. Reported to Vice President, International Division.
Years Employer Title Department
Years: 1977 to 1978 Employer: Litton Industries Title: MANAGER OF PRODUCT PLANNING, APPLICATIONS AND PROFESSIONAL EDUCATION Department: Medical Division
MANAGER OF PRODUCT PLANNING, APPLICATIONS AND PROFESSIONAL EDUCATION for Ultrasound division; directed new digital imaging project, regulatory affairs, product planning, vendor liaison, professional education and research & development; International travel 80 per cent. Reported to Vice President of Marketing.
Years Employer Title Department
Years: 1969 to 1977 Employer: Wake Forest University Title: CLINICAL SCIENTIST, INSTRUCTOR AND INVESTIGATOR Department: Bowman Gray School of Medicine
CLINICAL SCIENTIST, INSTRUCTOR AND INVESTIGATOR in diagnostic and therapeutic Ultrasound, Neurology and Neurosurgery. Investigator for projects in hydrocephalus, peripheral vascular disease, cerebrovascular disease and acute head trauma; Supervision of technical and research staffs; Management of ultrasound research grants; Designed and maintained biostatistics database. Reported to ultrasound pioneer / neurologist Expert M. McKinney, MD.

Career Accomplishments

Associations / Societies
· Full Member, Society of the Sigma Xi
· Full Member, American Institute of Physics (AIP)
· Full Member, Federation of American Scientists (FAS)
· Full Member, North Carolina Academy of Science (NCAS)
· Emeritus Member, New York Academy of Sciences (NYAS)
· Member, Medical Group Management Association (MGMA)
· Member, International Society for Optical Engineering (SPIE)
· Member, Association of University Technology Managers (AUTM)
· Full Member, American Association of Physicists in Medicine (AAPM)
· Member, IEEE – Engineering in Medicine and Biology Society (IEEE-EMB)
· Senior Member and pending Fellow, American Institute of Ultrasound in Medicine (AIUM)
Licenses / Certifications
Certified Clinical Surgical Specialist
Awards / Recognition
· Awarded Duke Endowment Fellowship to the Hospital Management Institute, Graduate School of Business Administration, Kenan Flagler School, University of North Carolina at Chapel Hill, 1985
· Proofed and edited Vascular ultrasound of the neck: an interpretive atlas by Antonio Alayon, MD, PhD and Expert M. McKinney, MD; published by Lippincott Expert & Wilkins; 1st edition November, 2000
· Elected to Group on Business Affairs, Association of American Medical Colleges (AAMC), 1986
· Emeritus member of the New York Academy of Sciences (NYAS)
· Executive Secretary of the American Institute of Ultrasound in Medicine (AIUM), 1973 – 1977
· Editorial and Research Advisor to Emeritus Faculty of the Wake Forest University School of Medicine
· Service on numerous standing and ad hoc committees of the American Institute of Ultrasound in Medicine
· Successfully negotiated the first sale of U.S.-manufactured ultrasound and nuclear medicine equipment to the People’s Republic of China through a ten-day seminar held in Shanghai
· Voting Delegate of the AIUM to the World Federation of Ultrasound in Medicine and Biology (WFUMB)
· Tapped into the Society of the Sigma Xi (Honorary scientific research society), 1973
· Tapped into the Scientific Research Society of North America, 1973

Fields of Expertise

Request Expert

Dev Tool:

Request: expert/medical-surgical-device-design-management-marketing-regulatory
Matched Rewrite Rule: expert/([^/]+)(?:/([0-9]+))?/?$
Matched Rewrite Query: experts=medical-surgical-device-design-management-marketing-regulatory&page=
Loaded Template: single-experts.php